MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. UNCUFFED CLEAR PVC SOUTH POLAR PREFORMED MURPHY EYE TRACHEAL TUBE; TUBE, TRACHEAL (W/WO CONNECTOR)

Catalog Number	100/136/070
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/30/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received that a smiths medical endotracheal tube was reported to have a persistent leak.Report of hole in tube.No patient injury resulted.
Additional Manufacturer Narrative
One photograph was returned for evaluation.A hole was observed from the photograph received.In order to reproduce the failure mode a sample was taken from the production floor and inflation line operation was performed applying more force than required with the bradawl.Results were that the brawdawl pierced the inflaton channel.The most applicable root cause was determined to be the application of strong pressure when inserting the bradawl.This investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.

• Brand Name: UNCUFFED CLEAR PVC SOUTH POLAR PREFORMED MURPHY EYE TRACHEAL TUBE
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7656436
• Report Number: 3012307300-2018-02593
• Device Sequence Number: 156823
• Product Code: BTR
• UDI-Device Identifier: 15019315021312
• UDI-Public: 15019315021312
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K931735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Catalogue Number: 100/136/070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2018
• Supplement Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 07/02/2018
• Supplement Report FDA Received Date: 11/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention